Synbiotic-supplemented organic formula enhances infant gut health: a randomized controlled trial

Background: Background: Infant gut health is crucial for long-term well-being, with early microbial colonization playing a pivotal role. Organic infant formulas are increasingly sought after, and synbiotics, combining prebiotics and probiotics, have shown promise in promoting beneficial gut microbiota. This randomized controlled trial investigates the impact of a synbiotic-supplemented organic formula on infant gut health. Objective: This study conducted a dual-center, double-blind, randomized, parallel-controlled trial to evaluate the effects of two cow's milk-based formulas—organic protein milk and organic protein milk with Bifidobacterium animalis subsp. lactis BB-12® and prebiotics DiGenix®—as well as breastfeeding, on gastrointestinal health and growth in infants aged 30 to 120 days. Methods: Seventy-five healthy full-term infants were enrolled and divided equally into three groups: breastfeeding, organic protein milk formula, and organic protein milk with BB-12® and prebiotics DiGenix® formula. The study included four pediatric follow-ups at 30, 60, 90, and 120 days after birth, before the introduction of complementary feeding. Results: Infants in the organic protein milk with BB-12® and prebiotics DiGenix® and breastfeeding groups had significantly softer stools and higher bowel movement frequencies at 90 and 120 days compared to those in the organic protein milk group, suggesting better gastrointestinal health due to the inclusion of BB-12® in organic protein milk with prebiotics DiGenix®. Growth parameters (weight, length and head circumference) and sleep patterns were similar across all groups, indicating that all feeding methods provide adequate nutrition and similar sleep quality. However, less gastrointestinal discomfort (bloating and burping) was observed in the organic protein milk with BB-12® and prebiotics DiGenix® and breastfeeding groups, indicating better digestive tolerance. The safety profile was comparable across all groups. Novelty of the study: This study is among the first randomized controlled trials comparing organic protein milk formula enriched with Bifidobacterium animalis subsp. lactic BB-12® and prebiotics DiGenix® to breastfeeding and standard formula in infants. The findings demonstrate significant improvements in gastrointestinal health, including softer stools, increased bowel movement frequency, and reduced digestive discomfort, positioning this formulation as a safe and effective alternative to breastfeeding. Conclusions: These findings support organic protein milk with Bifidobacterium animalis subsp. lactis BB-12® and prebiotics DiGenix® as a safe and effective alternative to breastfeeding for promoting gastrointestinal health. Further research is needed to optimize formula composition and assess long-term health outcomes. Keywords: Infant Nutrition, Gastrointestinal Health, Cow's Milk-Based Formula, Bifidobacterium animalis subsp. lactis BB-12®, Randomized Controlled Trial